Specified Drug-Use Survey of Leuprorelin Acetate Injection Kit 11.25 mg "All-Case Investigation: Spinal and Bulbar Muscular Atrophy (SBMA)"

Takeda

Status: Enrolling

Conditions: Spinal and Bulbar Muscular Atrophy

Treatments: Drug: Leuprorelin Acetate

Study type: Observational

Funder types: Industry

Identifiers

NCT03555578

Leuprorelin-5004

JapicCTI-183981 (Registry Identifier)

Details and patient eligibility

About

The purpose of this survey is to evaluate the long-term safety and efficacy of leuprorelin acetate injection kit 11.25 mg in patients with spinal and bulbar muscular atrophy (SBMA) in the routine clinical setting.

Full description

The drug being tested in this survey is called leuprorelin acetate injection kit 11.25 mg. This injection kit is being tested to treat people who have SBMA.

This survey is an observational (non-interventional) study and will look at the long-term safety and efficacy of the leuprorelin acetate injection kit 11.25 mg in the routine clinical setting. The planned number of observed patients will be approximately 300.

This multi-center observational trial will be conducted in Japan.

Enrollment: 1,890 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• All SBMA patients who have been confirmed as receiving the drug

Exclusion criteria

• None

Trial design

1,890 participants in 1 patient group

Leuprorelin Acetate 11.25 mg

Description:

Leuprorelin Acetate Injection Kit 11.25 mg, every 12 weeks subcutaneously, for up to at most 8 years. Participants received interventions as part of routine medical care.

Treatment:

Drug: Leuprorelin Acetate